Methods | Twelve-week randomised, double-blind, multicentre study. | |
Participants | Outpatients fulfilling DSM-III-R criteria for major depressive disorder, with a score of at least 18 on the HDRS-24. Age range: over 70 years old. Exclusion criteria: any significant medical problem, criteria for any other Axis I psychiatric or neurological disorder, any cognitive impairment, suicidal risk, drug abuse or dependence, any medical controindication to study medications, history of failure to respond to either ECT or adequate trials with two or more antidepressants |
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Interventions | Fluoxetine: 33 participants. Sertraline: 42 participants. Fluoxetine dose range: 20-40 mg/day. Sertraline dose range: 50-100 mg/day. |
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Outcomes | Hamilton Rating Scale for Depression (HDRS-24), Hamilton Rating Scale for Anxiety, CGI Severity and Improvement, POMS, Q-LES-Q | |
Notes | Response: decrease of at least 50% in the HDRS-24 total. Remission: total score of maximum 7 on the HDRS-24 at the week 10 and 12. Funding: by industry |
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Risk of bias | ||
Item | Authors’ judgement | Description |
Allocation concealment? | Unclear | B - Unclear |